Infustion device and method



D United States Patent [1113,538,915

[ 72] Inventors Den-ell N. Fnmpton 2,989,053 6/1961 Hamilton 128/221 Pleasant Grove; 3,179,107 4/l965 Clark 128/221 James C. lnveless,Mldvale, Utah 3,463,152 8/1969 Sorenson l28 /221X fir:- 5 1968 FOREIGN PATENTS 1 i e p Patemed N. 10, 1970 864,007 3/1961 Great Britain 128/221 [73] Assignee Deleret Pharmaceutical Company, Inc. Primary Examiner-wamef Camp S U h Att0rney--Lynn G. Foster 4 INF SION DEVICE AND METHOD [5 l U ABSTRACT: An infusion device and method, the device in- 11 Claims, 11 Drawing Figs. I eluding an infusion needle received by and cemented in fixed [52] US. Cl. 128/214, mkmon to a one piece ,needlemolding member or insane; 128/221 which has been folded as separate halves about one end of the [51] IIILCIMU, A6lln 5/00; needle and remains in the folded State when the cement or A611 5/32 bonding agent has cured. This final product presents a unitary [50] Field of Search 128/214, which may be grasped by the fingers for precise, a joint 221, 348 manipulation of the needle, the tab being formed of two wing portions or halves initially disposed on opposite sides of the [56] References Cited fold line, which when oppositely arcuately displaced about the UNITED STATES PATENTS fold line into contiguous bonded relation present the unitary 2,725,058 1 1/1955 Rathkey 128/221 tab offset to one side ofthe needle,

Patentgd Nbv. 10,1970 I 3,538,915

INVENTORS DARRELL N. FRAMPTON JAMES c. LOVELESS ATTORNEY 1 74 9 W 1 FIG. 9 82 FIG. IO a? to a unique method of this invention, infins production form and thereafter used for accurate and effectiveplacement and maintenance of an infusion needle with a vein.

Priorart infusion needle assemblies of the type disclosed in US. Pat. Nos. 1,157,524; 2,725,058; and 3,064,648 are generally designed for intravenous administration of fluids and comprise laterally disposed flexible wings. The fabrication'of these prior art infusion assemblies haspreviously principally comprised press-fitting the wing portionsonto the needle structure or,frequently, permanently attaching plastic wings tothe needle structure by moldingithe'flexible wings-directly onto the needle structure.

In using prior art infusion needle assemblies it-has been comparatively difficult to effectively force the needle through tough skin and to precisely manipulate the needle by use of flexible wings which yield relative to the needle under such force. Moreover, if all wings and the like are not adapted to lie flat against the skin following venipuncture there is a significant likelihood that the needle may be inadvertently dislodged from the vein or pushed throughanother portion of thevein wall. The small gauge needles generally .usedin infusion assemblies frequently become obstructed or lodged with the bevel of the needle adjacent the vein wall at somepointin time after the needle'has been placed within the veinflt has been found that mere rotation of the needle withinthe vein will free the needle passageway from obstruction by the vein wall and again allow relatively free fluid flow. Prior art devices do not readily accommodate such rotation of the needle once 1 the needle has been" inserted into-the vein because the assembly can be taped or otherwise fixed in only one needle orientation within the vein.

The present invention provides a novel intravenous infusion unit'and method wherein a single rigid blankcomprising two oppositely'disposed halves-may be rapidly and easily folded around and attached, as by bonding, to a conventional infusion needle to provide an inserter comprising a single essentially radially-extending tab or handle disposed radially to one side of theneedle and an integralbody portion nonrotatably attached to the needle. I I

Accordingly, it is a primary object of the 'presentinvention to provide an improved intravenous infusion unit which may be rapidly and effectively assembled and which accommodate precise control of the needle during-placement and maintenance within a vein or the like.

It is another important object of thepresent invention to provide a novel method of permanently assembling a needle and rigid inserter tab structure to form an improved infusion unit.

These and other objects and features of the present invention will become more fully apparent from the following description and appended claims taken in conjunction with the accompanying drawings wherein: I

FIG. 1 illustrates in top perspective one presently preferred embodiment of the blank structure, used to form the inserter, in its initial pos'tmolded state;

FIG. 2 illustrates in .bottom perspective the blank structure ofFIG.l;

FIGS. 3 and schematically illustrate preferred method steps relied upon in assemblying thefblank and needle to form one presently prefrrd infusion unit;

FIG. 5 illustratesinschematic perspective the one presently preferred infusion unit permanentlyassembled according to the method step shown'in FIGS. 3 and4;

FIQ 6 is a cross section taken along lines 61-6 of FIG. 5',

FIG: 7 illustrates in top perspective another presently preferred blank structure in its initial postmolded state;

FIGI8 illustrates the blank structureof FIG. 7 in fragmentary bottoin perspective;

FIG.9 is a cross section taken along lines 9 9 of FIG. 7;

FIG. 10 is a cross section taken along lines 10-10 of FIG. 7; and

With reference to- FIG. '1, one-presently preferred embodiment of the blank structure 20 is illustrated in its open, post molded state. The blank structure 20 is preferably formed of a substantially stiff plastic material, such as polyethylene or polypropylene, using conventional molding. techniques and structurally comprises wings or half portions 22 and 24 disposed in essentially a single plane. Wings 22 and 24 present, as shown in FIG. 1, substantially flat planar surfaces 26 and .28. Planar surface 26 presents, essentially central thereof, a-projecting disc 30, the purpose for which will be hereinafter described. The wing 24 is provided with a centrally disposed aperture 32 and adapted to receive disc in mating relation.

A needle-engaging body 34, is, in the embodiment illustrated in FIGS. l--6, divided into two substantially similar portions 36 and 38. Body portions 36 and38 project forwardly beyondthe forward edge of each wing 22 and 24 and form rounded leading end portions 42 and 44. The body portions 36 and 38 likewise project rearwardly beyond the trailing edge 37 of each wing 22 and 24 to form trailing members 46 and 48 of tube-attaching structure 47. The body portions 36 and 38 are separated by a weakened portion 41 (see especially FIG. 2), which accommodates opposite relative radial displacement or folding of the wings 22 and 24 about a properly sized needle.

Semicylindrical grooves 50 and 5 2 respectively extend along parallel axes throughout the entire axial length of the body portions 36 and 38, the grooves 50 and 52 respectively being interrupted at axially juxtaposed locations by recesses 54 and56. The recesses 54 and 56 are adapted to receive a suitable liquid adhesive or other suitable bonding'agent 58 (FIGS..3 and 4), such as epoxy, immediately prior to assembly. h I

With reference to FIGS. 3 and 4, one suitable method of making an infusion assembly from the planar blank 20 and a hypodermic needle 60 will now be described. With the wings 22 and 24 disposed generally horizontally, adhesive 58 is deposited in each of the'recesses 54 and 56 sufficient to generously fill the recesses. The needle 60 is generally oriented with its axis in a plane somewhat parallel to the plane containing the blank 20, such that the sharp bevel 62 thereof is located well forward of the leading end portions 42 and 44 and the trailing end 64 of the needle 60 is located only a relatively short distance rearward of trailing projections 46 and 48. As best illustrated in FIG. 4, the needle 60 is placed in one axial groove, shown as the axial groove 52 with the pointed tip of the needle bevel 62 disposed in the plane containing the weakened portion or fold line 41. Obviously, the size of grooves :50 and 52 must be compatible with the diameter of the needle 60 and vice versa.

With the needle 60 properly oriented within the groove 52, the wings 22 and 24 are moved arcuately relative to each as indicatedby arrows 61 and 63 (FIG. 4), the movement being essentially pivotal about the weakened portion or fold line 41. The projecting element 30 will thus be snugly received by the correspondingly sized aperture 32, and the flat faces 26 and 28 will meet. The' groove 50 will then be disposed over the shank of the needle 60 opposite the groove 52 and the adhesive 58, displaced to conform to the peripheral shape of the needle, will permanently fix the needle 60 within the body 34, when set. If desired, the edge of the aperture 32 may be coated with suitable adhesive to better establish a bond with disc 30.

The resulting structure, illustrated in FIG. 5, is a unitary infusion assembly comprising a unitary tab 121 and permanently attached needle 60. When the needle 60 and tab I21 are assembled as illustrated in FIG. 5, a suitable catheter or tube 66 is normally attached at projections 46 and 48 of the tube attaching structure 47, by a press-fit relation, bonding or the like. The rounded forward projection of the needle engaging body 34 is adapted to receive in press-fit relation one end described. Referring now to FIG. 7, the generally planar blank structure, generally designated 70, is preferably formed of a rigid or stiff plastic material and comprises, in the initial postmolded condition, opposed wings 72 and 74 which, initially, exist in a common plane. Essentially central of the wing 74 is an outwardly projecting disc 76, shown in cross section in FIG. 10. The element 76 is provided with an enlarged peripheral flange 78, followed by a reduced diametral portion 79, the purpose for which will be hereinafter more fully described.

The wing 72 is centrally provided with a stepped aperture 80, more clearly illustrated in the cross section in FIG. 9. The stepped aperture 80 is sized and shaped so as to snugly receive the peripheral flange 78 and reduced portion 79 of the disc 76. Thus, when the wings 72 and 74 are sufficiently relatively arcuately rotated, the stepped disc 76 and the matching stepped aperture 80 engage to form a locked joint, after the larger flange 78 has been forced to snap through the smaller diameter portion of the aperture 80. Bonding agent may also be used, if desired. A needle-receiving body portion 84 of the blank 70 is similar to the body 34 of the embodiment of FIG. 1 and comprises forwardly-projecting members 86 and 88 which are separated by a weakened portion or fold line 90 accommodating the mentioned relative arcuate displacement or folding of the wings 72 and 74. Suitable bonding agent or adhesive is placed in widened portions 99 and 101 of axially extending grooves 103 and 105. Grooves 103 and 105 receive a hypodermic needle the same way as described in conjunction with the embodiment of FIG. 1.

Then, in fully assembled relation, the external appearance of the infusion assembly of FIGS. 7-ll is substantially the same as that depicted in FIG. 5.

The tube-attaching, rearwardly projecting structure 94 comprises axially projecting members 96 and 98, each being respectively provided with notches 100 and 102. When the blank 70 is folded in assembled relation, the notches 100 and 102 cooperate to more securely retain a tube (not shown), similar to the retention of tube 66 (FIG. The tube, of smaller diameter than the diameter of structure 94 in the folded position, is forced over projections 96 and 98 to engage the notches 100 and 102 adjacent tapered surfaces 104 and 106 respectively disposed in the wings 72 and 74.

In using the presently preferred embodiments of the invention to penetrate the skin and vein of a patient, the tab, such as tab 121, is grasped between the thumb and forefinger essentially perpendicular to the surface to be penetrated and the needle bevel, face up, is forced through the flesh into the vein. It should be appreciated that even the toughest skin can be easily penetrated because resistance to the needle can be directly compensated for by increased pressure upon the tab by the user without appreciable relative yielding between the tab and the needle. The fact that the tab is rigid and rigidly joined to the needle accommodates precise control of the needle throughout the venipuncture operation. Subsequent to successful venipuncture, the tab and connected needle may be unitarily rotated in either direction to tape the infusion assembly in place or to rotate the infusion assembly to enhance fluid flow through the needle.

The invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore to be embraced therein.

We claim:

1. In a method of inseparably securing an infusion needle to a rigid inserter:

providing a blank comprising opposed wing portions separated by a connection portion comprising fold line and spaced parallel needle-receiving grooves one on each side of the fold line;

placing the shank of the infusion needle adjacent the conne ct ortion; relative y arcuately displacing the wing portions about the fold line into contiguity bringing both needle-receiving grooves into contact with the needle; and

permanently joining the connection portion to the shank of the needle and the wing portions one to the other to form a unitary tab.

2. In a method as defined in claim 1 wherein said placing step comprises contiguously situating the needle in one of two grooves and wherein said displacing step comprises relatively folding the wing portions to locate the other groove contiguous with the needle so that a portion of the needle shank is circumscribed by the needle-receiving member.

3. An intravenous infusion set for venipuncture placement and retention in the cardiovascular system to accommodate fluid flow from time to time and comprising a needle assembly comprising a hollow needle having a sharp leading end for making a venipuncture, a single inserter of essentially rigid material comprising a generally planar tab having two generally flat sections joined by a connection edge portion wrapped around and substantially inflexibly and inseparably uniting the inserter to the exterior of the needle rearward of the sharp leading end of the needle, the tab (a) having at least one needle-receiving groove adjacent to and parallel with the connection edge portion and (b) projecting laterally in essentially a single direction from the connection edge portion and the needle, the trailing edge of the inserter being closely juxtaposed the trailing end of the needle assembly, the tab being folded about the connection edge portion into contiguous, inseparable relation.

4. An Infusion set as defined in claim 3 further comprising spaces containing adhesive between the connection edge portion and the exterior of the needle.

5. Art infusion set as defined in claim 3 wherein one said flat section presents at least one male fastening structure and the other flat section presents snugly matching female fastening structure.

6. An infusion set as defined in claim 5 wherein the male fastening structure comprises a disc and the female fastening structure comprises a correspondingly sized and shaped aperture.

7. An infusion set as defined in claim 6 wherein the disc and aperture are stepped.

8. An infusion set as defined in claim 3 wherein said connection edge portion presents forwardly projecting structure to receive a needle sheath and rearwardly projecting structure to receive a tube to accommodate fluid flow and wherein the needle-receiving groove opens to the exterior of the tab at both the forwardly and rearwardly projecting structures.

9. In an infusion instrument comprising opposed rigid wings folded and fastened together in surface-to-surface relation to form only a single rigid tab and a hypodermic needle securely eccentrically held between the fastened wings at the fold.

10. A blank of stiff plastic material comprising two similar flat sections disposed on opposite sides of a connection portion having a central axial weakened midportion and axially extending parallel semicylindrical grooves respectively disposed at spaced locations in the connection portion on opposite sides of the weakened midportion to contiguously receive the shank of a hypodermic needle when the flat sections are relatively pivoted about the midportion, each flat section having fastening means to hold the sections together after the flat sections have been relatively pivoted.

11. An intravenous needle assembly comprising a relatively short hollow needle having only one sharpened tip at the front end thereof for penetrating the skin, a single tab connected to and essentially radially projecting from the exterior of the needle so that a relatively long portion of needle projects forward of the tab, the tab comprising opposed rigid sections disposed on opposite sides of the plane containing the axis of the needle and parallel opposed grooves for receiving the needle, the sections being fastened one to the other in face-to-face relation. 

